EUCTR2016-001777-33-DE进行中（未招募）1 期
EVALUATION OF CEREBRAL THROMBOEMBOLISM AFTER TAVR - EARTH TAVR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Potential patients must satisfy the following criteria to be enrolled in the study:
- •- Man or woman of 18 years of age or older, who are planned for TAVR
- •- TAVR of a native aortic valve stenosis
- •- By iliofemoral or subclavian access
- •- With any approved/marketed TAVR device
- •- EARTH Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 207
排除标准
- •Patients are NOT eligible to participate in this study if they meet ANY of the following
- •exclusion criteria:
- •1. Any atrial fibrillation (AF), at the time of randomization or previous, with an ongoing indication for oral anticoagulant treatment
- •2. Any other indication for continued treatment with any oral anticoagulant (OAC)
- •3. Any contraindication for cerebral MRI, in particular:
- •- non-MRI-conditional pacemakers
- •- MRI conditional pacemakers <4 weeks after implant
- •- any metal fragments in the eye
- •- aneurysm clip in the brain
- •- severe claustrophobia
- •Bleeding risks or systemic conditions
- •4. Known bleeding diathesis, such as but not limited to:
- •a. active internal bleeding, clinically significant bleeding, bleeding at a non-
- •compressible site, or bleeding diathesis,
- •b. platelet count = 50,000/mm3 at screening
- •c. Hemoglobin level < 8.5 g/dL
- •d. history of intracranial hemorrhage or subdural hematoma
- •e. major surgery, biopsy of a parenchymal organ, or serious trauma within 30 days before randomization
- •f. active peptic ulcer or known upper GI bleeding within the last 3 months
- •Concomitant and study medication
- •5. Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months’ after TAVR (such as coronary, carotid or peripheral stent implantation)
- •6. Known hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel or rivaroxaban or hypersensitivity to contrast media that could not be solved neither by switching to an alternate contrast media nor with pre-treatment with appropriate medication
- •7. Routine use of oral non-steroidal anti-inflammatory drugs (NSAID)
- •8. Concomitant therapy with systemic drugs that are strong inhibitors of both CYP3A4 and P-gp (azole antimycotics such as ketoconazole and itraconazole or HIV protease inhibitors such as ritonavir)
- •9. Concomitant therapy with drugs that are strong CYP 3A4 inducers (e.g. carbamazepine, phenytoin, rifampin, St. John’s wort)
- •10. Concomitant therapy with omeprazole or esomeprazole that cannot be switched to an alternate medication.
- •Concomitant conditions
- •11. Planned coronary or vascular intervention or major surgery
- •12. Clinically overt stroke within the last 3 months
- •13. Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis before TAVR, or unresolved kidney injury with renal dysfunction stage 2 or higher
- •14. Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
- •15. Active infective endocarditis
- •16. Active malignancy (diagnosed within 5 years) except for adequately treated Nonmelanoma skin cancer or other non-invasive or in situ neoplasm (e.g.,cervical cancer in situ that has been successfully treated)
- •Other exclusion criteria
- •17. Dementia or forgetfulness hindering compliance with medication intake or other Study procedures
- •18. Legally incompetent to provide IC
- •19. Previous (30 days before enrolment) or concomitant participation in another clinical study with investigational medicinal product(s).
- •20. Previous assignment to treatment during this study
- •21. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site) or sponsor
- •22. Female of childbearing potential
- •a. Who are not surgically sterile, or who are sexually active and not willing to use adequate contraceptive measures with a failure rate
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